510(k) K111323

SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS by Synthes, Inc. — Product Code KKY

K111323 is an FDA 510(k) premarket notification submitted by Synthes, Inc. for the device "SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS". The FDA issued a decision of Substantially Equivalent on November 16, 2011. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500. Synthes, Inc. has at least 10 other 510(k) clearances on record.